Fundamentals of Canadian Pharmacovigilance

  • April 26, 2017
    9:00 am - 4:30 pm

Location

6700 Trans-Canada Hwy, Pointe-Claire, Quebec, Canada, H9R 1C2
RA

Certification Areas

Event Objective

This course is intended to provide a basic overview of post-market adverse drug reaction reporting requirements in Canada.

Event Description

1. Introduction to Pharmacovigilance

This section introduces the audience to Pharmacovigilance, its scope and the international standardization of the Reporting of Adverse Drug Reactions.

 

2. Post-Marketing Adverse Drug Reaction Reporting in Canada- Individual Case Safety Reports

This section includes a presentation and a discussion on the Canadian Food and Drug Regulations and Health Canada’s guidances for the reporting of adverse drug reactions occurring in the Post-Approval period.

 

3. Post-Marketing Adverse Drug Reaction Reporting in Canada – Summary Reports

This section includes a presentation and a discussion on the Canadian Food and Drug Regulations and Health Canada’s guidance for the reporting of annual summary reports and issue-related summary reports in the Post-Approval period.

 

4. Risk Management Plans in Canada

A brief overview of Risk Management Plan requirements in Canada will be provided

 

5.Good Pharmacovigilance Practice (GVP) Inspections in Canada

This section will review Health Canada’s GVP inspection process and will provide participants with useful tips to prepare for inspections.

Who should attend?

Individuals in Drug Safety/Pharmacovigilance, Regulatory Affairs and Quality Assurance who have limited or no pharmacovigilance experience. It can also serve as a refresher course for individuals with more experience in Pharmacovigilance.

Speaker

Registration Deadline: 24 Apr 2017